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“Super-surgeon” who created artificial tracheas facing new misconduct allegations

Paolo Macchiarini

A one-time media favorite is being accused of serious misconduct in three cases where he inserted artificial windpipes into patients and treated them with stem cells. Two of the patients have died; one survives, but needs her airway cleaned every four hours by hospital staff to keep her alive.

A little over two years ago, thoracic surgeon Paolo Macchiarini soared to the top and then sunk to the bottom within days. First, his work implanting artificial tracheas hit the front page of the New York Times. Days later he was placed on house arrest for accusations of fraud and extortion.

The complaints against Dr. Macchiarini were lodged in the form of letters to the institute, copies of which were obtained by The Times. They assert that there is no evidence that the experimental operations — considered “compassionate use” because the patients were said to have few if any alternatives for survival — had been subject to ethical review. According to the complaints, only one of the patients, the Eritrean man, appeared to have signed a consent form for the operation, and in that case the form was dated more than two weeks after the surgery, according to a copy of the document included with the complaints.

The Eritrean man’s case was the subject of a paper, described as a “proof of concept study,” by Dr. Macchiarini and others that was published online in the British medical journal The Lancet on Nov. 24, 2011, five and a half months after the synthetic windpipe was implanted.

Fountain goes on explain that, while the paper indicated there were no complications, Macchiarini conducted a surgery on the patient prior to publication that indicated serious problems with the implant.

The NYT spoke to Macchiarini about the case:

Reached in Krasnodar, Russia, where he has done his most recent operations, Dr. Macchiarini said the accusations against him were unfounded.

From the NYT article: “One of the doctors who filed the complaints, Karl-Henrik Grinnemo, is himself the subject of a complaint by one of Dr. Macchiarini’s colleagues, Philipp Jungebluth. Dr. Jungebluth has accused Dr. Grinnemo of ethical breaches in connection with a grant Dr. Grinnemo received from the Swedish government.” Dr. Grinnemo is one of the co-authors of the paper published on Lancet in 2011: if he thought that the paper was falsifying the results, why did he signed it? Why did he wait 3 years to talk? Maybe because of the complaints against him and his friends? This sounds like a revenge!